eCTD NEWS
RECENT NEWS
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EMA IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated) Provisional mandate, objectives and rules of procedure for the Nitrosamines Safety Operational Experts Group (NS OEG) Medical...
EMA Template or form: CHMP protocol assistance scientific advice briefing document template (updated) Newsletter: News bulletin for small and medium-sized enterprises - Issue 58 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised...
EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated) eSubmissions (eCTD) Updated...
EMA Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams (updated) Template or form: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical Clinical Trials Information System...
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EMA Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (updated) Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics -...
EMA Clinical Trials Information System Webinar: Second Year of Transition , Online, 13:00 - 17.30 Amsterdam time (CET), from 04/07/2023 to 04/07/2023 (updated) Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission , Online, 15:30 - 17:00 Amsterdam time...
EMA Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages Template or form: QRD Appendix V - Adverse-drug-reaction reporting details(updated) eSubmissions (eCTD) Updated PLM Portal eAF Release notes now available An updated version of the PLM...
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